| Eligibility |
Inclusion Criteria:
1. Participant is aged =18 and =35 years and in good health.
2. Rechallenge group only: participation in CoGA study, having received immunisation with
1x 50 GA2-infected MB, and protected during subsequent CHMI.
3. Participant has adequate understanding of the procedures of the study and agrees to
abide strictly thereby.
4. Participant is able to communicate well with the investigator.
5. Participant is available to attend all essential study visits.
6. Participant agrees that his/her general practitioner (GP) will be informed about
participation in the study.
7. Participant agrees to refrain from blood donation to Sanquin or for other purposes.
throughout the study period and for a defined period thereafter according to Sanquin
guidelines.
8. Participants of child bearing potential (i.e., have an uterus and are neither
surgically sterilized nor post-menopausal) agree to use adequate contraception and to
not breastfeed for the duration of study.
9. Participant agrees to refrain from intensive physical exercise (disproportionate to
the participants' usual daily activity or exercise routine) for twenty-one days
following the immunization and during the malaria challenge period.
10. Participant signs informed consent.
Exclusion Criteria:
1. Any history, or evidence at screening, of clinically significant symptoms, physical
signs or abnormal laboratory values suggestive of systemic conditions which could
compromise the health of the participant during the study or interfere with the
interpretation of the study results. These include, but are not limited to, any of the
following:
a. Body Mass Index (BMI) >35.0 kg/m2 at screening. b. An elevated risk of
cardiovascular disease, defined as: i. An estimated ten-year risk of fatal
cardiovascular disease of =5% at screening, as determined by the Systematic Coronary
Risk Evaluation 2 (SCORE2) . See Appendix 1 for the SCORE2 risk classification; ii.
History, or evidence at screening, of clinically significant arrhythmia's, prolonged
QT-interval or other clinically relevant ECG abnormalities; or iii. A positive family
history of cardiac events in first- or second-degree relatives (according to the
system used in medical genetics) <50 years old.
b. Known functional asplenia, sickle cell trait/disease, thalassemia trait/disease or
G6PD deficiency.
c. History of epilepsy in the period of five years prior to study onset, even if no
longer on medication.
d. Positive HIV, HBV or HCV screening tests. e. Chronic use of i) immunosuppressive
drugs, ii) antibiotics, iii) or other drugs that might have an influence on the immune
system (excluding inhaled and topical corticosteroids and incidental use of oral
anti-histamines), within three months prior to study onset or expected use of such
during the study period.
f. Skin disease affecting the site of administration in such a way that administration
of mosquito bites is deemed impossible by investigator.
g. History of malignancy of any organ system (other than localized basal cell
carcinoma of the skin), treated or untreated, within the past five years.
h. Any history of treatment for severe psychiatric disease by a psychiatrist in the
past year.
i. History of drug or alcohol abuse interfering with normal social functioning in the
period of one year prior to study onset, positive urine toxicology test for cocaine or
amphetamines at screening.
2. For participants of child bearing potential: breastfeeding, or positive serum
pregnancy test prior to CHMI.
3. Infection controls only: any history of malaria or previous participation in any
malaria (vaccine) study or CHMI.
4. Known hypersensitivity to or contra-indications for both atovaquone/proguanil or
artemether/lumefantrine. QT prolonging drugs are only considered an exclusion
criterion when QT prolongation is observed at the ECG at screening.
5. A history of severe (allergic) reactions to mosquito bites.
6. Participation in any other clinical study assessing an investigational medical product
in the 30 days prior to the start of the study or during the study period.
7. Any condition or situation that could influence the independent consent of participant
(e.g. being a direct colleague or family member of study personnel).
8. Any other condition or situation that would, in the opinion of the investigator, place
the participant at an unacceptable risk of injury or render the participant unable to
meet the requirements of the protocol or would compromise the integrity of the data.
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